EP3284511B1 - Electrode lead, implant and method for the identification of an electrode lead - Google Patents

Description

The invention relates to an electrode line for connection to an implant by means of a plug with at least one electrical conductor and an insulating jacket, a method for identifying an electrode line, an implant with a socket for connection to the plug of an electrode line, a method for configuring a system consisting of an implant and at least one electrode line and a readout adapter.

Implants (implantable medical devices, IMD) such as pacemakers, defibrillators or neurological devices such as brain pacemakers for deep brain stimulation, spinal cord stimulation devices, TENS (Transcutaneous Electrical Nerve Stimulator), devices for muscular stimulation therapy, or diagnostic devices that have the chemical properties of the patient's blood, other parts of the body or other body properties and parameters, often use electrode leads that are led into the patient's body and remain there at least for the duration of the treatment or measurement. The electrode lines are connected to the implant in an electrically conductive manner.

The implants usually comprise a body-compatible housing with an associated electronic circuit and a power supply, e.g. B. a battery. The housing has at least one socket to which one or more electrode lines can be connected, for example by means of a plug. An electrode line is used to transfer electrical energy or data from the housing to the treated or examined part of the body and vice versa.

In the context of the present invention, the term “electrode line” is understood to mean a line with at least one electrical conductor together with its enveloping insulating jacket and all other functional elements that are firmly connected to the line. The electrode lead usually also includes what is known as an electrode tip, by means of which the electrical energy is introduced into the tissue to be treated. Often an electrode tip is provided with anchor elements or holding structures with which the constancy of the spatial position of the transition point of the electrical energy into the tissue to be treated is ensured. Electrode lines can also contain one or more other elements such as, for. B. comprise a ring electrode or a helix, by means of which electrical energy is introduced into the tissue to be treated. The electrode tip can be designed as a discharge, stimulation or measuring electrode. Furthermore, the electrode line generally has a plug with which the electrode line can be connected to an implant, the plug being plugged into a socket of the implant for this purpose. The plug has one or more connections, each connection being connected to an electrical conductor of the electrode line, whereby this conductor can also consist of several parallel conductors that are insulated from one another.

Several electrode lines are often connected to modern implants, for example a multi-chamber pacemaker. The aim here is to make the electrode lines and their connections as thin or small as possible. On the other hand, this makes the clearly visible marking of the plugs and connections and the differentiation of the electrode lines more difficult. In addition, as the number of electrode lines increases, the risk of individual electrode lines being mixed up and / or incorrectly connected increases. It is therefore desirable if an implant recognizes which electrode lines are connected so that it can control them adequately. For this purpose, the electrode lines and / or their properties must be identifiable for the implant.

document US 2004/0073265 A1 describes a device that provides a means of detecting incorrectly connected coronary leads and / or incorrect connections to cardiac rhythm management devices. To do this, a A voltage application device of a pacemaker applies a voltage pulse between an electrode, which is connected to a lead with the pacemaker, and a head or housing electrode of the pacemaker. The housing electrode sends a connection signal. The electrode is used to measure a corresponding connection signal using the line. A measuring module of the device also measures one or more properties of the corresponding connection signal, such as its current strength, voltage, impedance and / or its time delay (after the voltage pulse has been transmitted). The signal properties can be influenced by one or more lines and / or by the transmitting tissue and fluids (for example a heart including one or more of its chambers) that lie in between. A comparison module of the pacemaker can then determine whether the line is properly routed to a contact of the pacemaker, one or more properties of the corresponding connection signal being compared with suitable preselected value ranges. For example, a measured impedance can be compared with an expected impedance range. The device described in the publication does not selectively identify the line, but rather tests whether the corresponding comparison signal, which is received via a line after stimulation of the body by a voltage pulse of a housing electrode of the pacemaker, has properties within a predetermined value range. The properties of the corresponding comparison signal are also determined by the stimulated body tissue between the housing electrode of the pacemaker and the receiving electrode. Only very gross deviations, such as those that occur due to an unconnected or completely wrong type of line, can be safely attributed to the line; minor deviations can be due to the body. The above-mentioned device can therefore not guarantee the reliable and targeted detection and differentiation of electrode lines with similar properties.

A similar device is also described in document US 2006/0212083 A1 disclosed. In this document, too, it is emphasized that the signal properties are influenced by the lines and / or by the tissue and fluid that are transmitted in between.

document US 2011/0112609 A1 describes a system for spinal cord stimulation with at least one implantable stimulation lead. In particular, it comprises a medical programming device and an implantable pulse generator which is connected to one or more implantable stimulation lines, each of which carries a plurality of electrodes. The stimulation lead has one or two lead bodies. The electrodes fit exactly into the epidural space of the spine. Since the tissue there is conductive, electrical measurements can be carried out between the electrodes. A control circuit of the implantable pulse generator records such electrical measurements so that the medical programming device can automatically identify the individual lead bodies that are connected to the implantable pulse generator. The electrical measurements of the control circuit to identify the connected lead bodies are field potentials. The control circuit can also measure the impedance at each electrode to determine the coupling efficiency between the respective electrode and the tissue and to determine the misidentification of the connection between the electrode and the analog output circuit of the implantable pulse generator. The known system has the disadvantage that the identification is not carried out by the implantable pulse generator itself, but by an additional medical programming device.

document US 2012/0123496 A1 illuminates connection detection and identification of the type of implanted lead for an implanted medical device. The device has a processor which can determine the connection and the line type of the line. First, a signal measuring module checks the connection of the lines by checking values of electrical parameters during a signal between at least two electrodes, in particular the impedance. One or more lines may have active electronics integrated therein that include one or more modular circuits integrated therein, depending on whether the line is unipolar or multipolar. Each of the modular circuits is capable of controlling a plurality of electrodes of the lead and includes circuitry that is electrically connected to one or more electrodes of the lead. As such, each of the modular circuits of a lead acts as an interface between the implanted one medical device and the electrodes to which the modular circuit is connected. To measure the impedance, the processor of the device controls the modular circuit so that it supplies a voltage pulse between a first and a second electrode. The signal measurement module measures the resulting current and the processor derives the impedance value. In a further step, the processor sends an interrogation signal along a first conductor of the line in order to receive a response from the modular circuits over a second line. Such a response from each modular circuit provides the processor with information about the modular circuit and the electrodes it controls. In a further configuration step, the processor sends a signal over the first line. The configuration step includes that the active configuration of the modular circuits is programmed. With regard to line designs and the active electronics or modular circuits used therein, reference is made to the document U.S. 7,713,194 referenced. According to this document, the modular circuit is designed in such a way that it is controlled by a bus. The pamphlet US 2012/0123496 A1 therefore describes that the additional interface electronics of modular circuits can be recognized and thus the electrode line can be determined. The known device has the disadvantage that complex modular circuits with active electronics must be implemented and programmed to control the electrodes. Furthermore, the information relates only to the modular circuits and the electrodes connected to them, not to the line as a whole.

A method and an apparatus for the automatic detection of implantable medical leads and their configuration are in the document US 2003/0018369 A1 shown. For this purpose, a first communication circuit, which stores data such as model and serial number, technical information and calibration data, is connected to or integrated into the line. This has a receiver and a transmitter in order to receive data signals from an external source. It can be programmed with identification data, calibration data and other data during manufacture. The first communication circuit is designed as a passive transponder and, in addition to the receiver and transmitter, also has an energy coupler for the energy supply and a control circuit which is connected to a non-volatile Storage is connected. The control circuit supplies the information to the transmitter / receiver of the transponder, which transmits the data via RF or other communication. During or after the implantation of the lead, the information can be transferred to a second communication circuit outside the lead. The transferred data can be used to identify the line, recorded in a patient file and transferred to a central memory for use by healthcare providers. Using the transponder, the line can be automatically recognized and the data stored in the memory can be transferred and passed on directly. In addition to a transmitter and receiver, the transponder requires a separate power supply, a control unit and a programmable, digital memory. As a result, the overall structure of the line is comparatively complex and expensive.

Also document US 2014/0343633 A1 provides an electrically identifiable electrode line with an identification module which has at least a filter, a power converter, a communication circuit, a load switch and a memory unit such as an EPROM for storing an identification code. Before the implant is inserted, each lead is implanted and connected to the implantable pulse generator (or an external pulse generator), which then reads out self-identifying data from the identification module and can transmit this information to an external device such as the doctor's programmer. The identification module can store up to 32 bytes of data for this purpose. This process is repeated for each lead that is implanted. The identification module uses two existing contacts on the line to connect to the implantable pulse generator. As in the aforementioned document, a digital memory is also required for this known electrode line and the structure of the identification module is similarly complex.

The object of the present invention is therefore to create an electrode line that can be identified reliably and unambiguously, but at the same time has a simple structure and can be manufactured inexpensively. The object is also to provide a simple method for identifying an electrode line, which allows an unambiguous assignment of an electrical conductor of the electrode line to a connection of the implant. The task is also to create a corresponding implant.

The above object is achieved by an electrode line having the features of claim 1.

The electrode line according to the invention has an ID circuit arranged in the insulation jacket with an ID chip, the ID circuit being connected with its first connection to an electrical conductor and with its second connection to an electrically conductive element exposed on the outside of the electrode line, wherein the ID chip has a memory unit and the electrically conductive element is arranged in the longitudinal direction of the electrode line at a predetermined distance from the plug, with at least one individual property of the electrode line in the memory unit, for example the ID number, lot number, type associated with the electrode line , Execution, revision or the like is stored. Additionally or alternatively, the at least one individual property can contain manufacturing data on the electrode line, the date and / or location of the implantation and / or the MRI approval.

The ID circuit, which is hermetically sealed to the outside in the insulation jacket and whose ID chip preferably has a single-wire interface, in which both the power supply and the information transfer takes place via a single common conductor and a return conductor, provides a signal path via an electrical conductor of the Electrode line, the ID circuit with ID chip, the electrically conductive element exposed on the outside of the electrode line, which is preferably designed as an electrically conductive ring, wire, rope, braid or foil, and the body tissue connected to the electrically conductive element back to the implant in the implanted state. The use of the body tissue as a return conductor to the implant housing is possible despite the non-negligible electrical resistance, since the currents required to operate the ID chip of the ID circuit are very low, for example in the range of 2 µA to 10 µA. The structure of the implant, especially in the area of the connections, must be used to identify the electrode lead cannot be fundamentally changed. In addition, the structure of the electrode line according to the invention is simple and inexpensive. The material of such an electrically conductive element can, for example, be one or more materials from the group containing Ti, Pt, Pd, Ir, Ni and Co and alloys thereof, for example MP35N or Pt / Ir, optionally with a preferably fractal coating of Ir or TiN, exhibit. It is important here that the surface of the electrically conductive element which is in contact with the body tissue, with a surface of at least 1 mm ^{2, is} sufficiently large to achieve the lowest possible contact resistance.

The single-wire interface is known in principle. This is a serial interface for bidirectional communication between a master and a slave in which data is usually transmitted asynchronously and in half-duplex mode, with both the energy supply and the information transmission taking place simultaneously via a single common conductor and a return conductor. With the single-wire interface, data is usually transmitted on the supply lines for the supply voltage by modulating the supplying current or the supplying voltage for data flows from the master to the slave and by means of load modulation for data flows from the slave to the master. Single-wire interfaces are implemented, for example, as 1-Wire® interface (Dallas Semiconductor Corp.), UNI / O® interface (Microchip Technology Inc.) or Highway Addressable Remote Transducer as HART standard (fieldbus standard IEC 61158). As a result, only two connections are required on the ID circuit, which are used both for the voltage supply and for communication with the ID chip. For this reason, too, the structure of the electrode line according to the invention is simple. Chips with a single-wire interface are commercially available at low cost. Due to the advantage of the single-wire interface of using a single data wire for power supply and as a transmit and / or receive line, electrode lines can also be identified which only have a single electrical conductor, for example unipolar electrodes or shock electrodes.

Another advantage of the electrode line according to the invention is that the ID circuit is not in the signal path between the connector and a Stimulation electrode pole lies. This does not impair the function of the electrode lead as a recording, stimulating or measuring electrode if the ID circuit should be defective.

In the case of the electrode line according to the invention, the use of RFID components can also be dispensed with. It thus represents an alternative to identification solutions using RFID technologies.

The formation of the electrically conductive element as an electrically conductive ring, wire, rope, strand or foil, which is arranged on and / or in the insulation jacket so that it is exposed on the outside and can be electrically contacted, leads to a good electrically conductive connection of the ID circuit to the body tissue.

It is also advantageous if the memory unit has a writable memory area so that, for example, implantation data, such as the implantation location or the implantation date, can be written into the ID chip so that this information is still available later.

The ID circuit particularly preferably has a switching transistor which is connected in parallel to the ID chip and is used for communication with the implant by means of load modulation.

In a preferred exemplary embodiment, the ID circuit has a voltage limiter parallel to the voltage supply connections of the ID chip in order to protect the ID chip from impermissibly high voltages, for example when a shock is delivered. For example, a Zener diode or a varistor can be used for this. For the energy supply during the load modulation, the ID circuit has a parallel connection of diode and buffer capacitor for energy supply.

• Verbinden des ersten Anschlusses des ID-Schaltkreises und des zweiten Anschlusses des ID-Schaltkreises mit der ID-Kommunikationseinheit des Implantats, wobei der erste Anschluss des ID-Schaltkreises mit einem vorgegebenen elektrischen Leiter der Elektrodenleitung und der zweite Anschluss des ID-Schaltkreises mit einem Gehäuse des Implantats verbunden wird,
• Anlegen einer Wechselspannung zwischen dem ersten Anschluss und dem zweiten Anschluss des ID-Schaltkreises,
• Auslesen mindestens einer gewünschten individuellen Eigenschaft aus der Speichereinheit des ID-Chips über eine Eindraht-Schnittstelle des ID-Chips mittels der ID-Kommunikationseinheit,
• Speichern der mindestens einen ausgelesenen individuellen Eigenschaft in einer Speichereinheit des Implantats.

The above object is also achieved by a method for identifying an electrode line described above by means of an implant with an ID communication unit, comprising the following steps:

• Connecting the first connection of the ID circuit and the second connection of the ID circuit to the ID communication unit of the implant, the first connection of the ID circuit with a predetermined electrical conductor of the electrode line and the second connection of the ID circuit with a housing of the implant is connected,
• Applying an alternating voltage between the first connection and the second connection of the ID circuit,
• Reading out at least one desired individual property from the memory unit of the ID chip via a single-wire interface of the ID chip by means of the ID communication unit,
• Storing the at least one individual property that has been read out in a memory unit of the implant.

The method according to the invention is characterized in that it can be carried out easily and leads to reliable identification of an electrode line. The use of alternating voltage for the power supply of the ID chip and the data communication with the chip is decisive for the method according to the invention. The voltages required for power supply and data communication are above the threshold for tissue stimulation. The alternating voltage used (preferably voltage U _eff from 2 V to 7 V; frequency f from 20 kHz to 500 kHz) prevents the tissue from being stimulated while the ID chip is being activated.

The method according to the invention enables at least one individual property of an electrode line, for example its serial number and / or its type, to be determined in a simple, inexpensive and fast manner. Another advantage of the method according to the invention is that the ID circuit can be stimulated as required. That saves energy. The ID circuit does not depend on a permanent power supply.

It is also preferred that the ID communication unit writes data predetermined via the single-wire interface of the ID chip into a writable memory area of the memory unit of the ID circuit. As already explained above, implantation data can thus also be stored in the electrode line.

The invention also relates to a method for configuring a system comprising an implant and at least one electrode line described above. According to the method, the at least one electrode line connected to the implant is first identified by means of a method described above and then the control of the connections of the implant connected to the identified electrode line and / or the therapy parameters are configured in accordance with the identified electrode line.

The above object is also achieved by an implant with a socket for connection to the plug of an electrode line, which is described above. The implant furthermore has a housing and an ID communication unit, the ID communication unit being set up for an electrically conductive connection to a predetermined electrical conductor of an electrode line and the housing of the implant and for generating an alternating voltage between the housing and the predetermined electrical conductor, wherein the ID communication unit is further set up for reading out at least one desired individual property of the memory unit of the ID chip, to which it is electrically conductively connected, via its single-wire interface and storing the at least one individual property read out in a memory unit of the implant. Another advantage of the invention is that the interrogating implant does not require any additional technology for measuring the characteristic variables of the ID circuit. Rather, by modifying the control, the existing electrical devices can be used to read out the at least one individual property from the ID chip of the electrode line or to write data into the writable memory area of the ID chip. A code of the individual property is preferably determined with the ID communication unit.

Another advantage of the implant according to the invention is that it can, if necessary, adapt the use and control of the electrode line based on the determined at least one individual property. This allows a safer, more effective use of the implant and the electrode lead and improves the success of the treatment.

According to the invention, a read adapter with a coil is also provided, the coil being connectable at its first end to a predetermined electrical conductor of the electrode line described above and at its second end to the electrically conductive element of the electrode line. This connection is designed, for example, as a contact terminal which protrudes into a recess (socket) arranged in the readout adapter for inserting the plug of the electrode line. Alternative contact options are also conceivable. The coil is preferably expanded into a resonance circuit by suitable wiring with a capacitor, the resonance frequency of which preferably corresponds to the operating frequency of an RFID read-out device different from the implant. The 125 kHz band, for example, can be used as the working frequency. Before use, the electrode line according to the invention can be stored together with the read-out adapter in the plugged-in state in a closed sterile packaging, the at least one individual property being contactless via the read-out adapter and, for example, a conventional RFID read-out device by means of inductive coupling between the coil of the read-out adapter and a corresponding coil the RFID readout device can be read out.

On the basis of the at least one individual property, in particular a serial number, further individual properties of the electrode line can optionally be determined, for example the type and / or type of electrode line, the intended use, an intended place of use, the time of manufacture, the maximum service life, a specific electrical Property, a number of electrodes, the type and / or type of connected electrodes, an electrode configuration, the number of therapeutic and / or diagnostic conductors, the length and / or the cross-section of therapeutic conductors, information on control or the like. Especially Such further individual properties can preferably be taken from the storage device of the implant, preferably with a database.

The invention is explained below using exemplary embodiments and with reference to the figures. All of the features described and / or shown in the figures form the subject matter of the invention individually or in any combination, regardless of how they are summarized in the claims or their references.

Fig. 1

ein Ausführungsbeispiel einer erfindungsgemäßen Elektrodenleitung in einem Längsschnitt,

Fig. 2

das Ausführungsbeispiel gemäß Fig. 1 in einem Querschnitt,

Fig. 3

eine Schaltskizze für einen ID-Schaltkreis der Elektrodenleitung gemäß Fig. 1,

Fig. 4

eine Schaltskizze eines erfindungsgemäßen Implantats zum Auslesen der in Fig. 1 dargestellten Elektrodenleitung,

Fig. 5

das steckerseitige Ende des in Fig. 1 dargestellten Ausführungsbeispiels einer Elektrodenleitung, teilweise geschnitten, und

Fig. 6

einen erfindungsgemäßen Ausleseadapter mit eingesteckter Elektrodenleitung gemäß Fig. 1 und eine sterile Verpackung in einem Querschnitt.

They show schematically:

Fig. 1

an embodiment of an electrode line according to the invention in a longitudinal section,

Fig. 2

the embodiment according to Fig. 1 in a cross section,

Fig. 3

a circuit diagram for an ID circuit of the electrode line according to FIG Fig. 1 ,

Fig. 4

a circuit diagram of an implant according to the invention for reading out the in Fig. 1 electrode lead shown,

Fig. 5

the plug-side end of the in Fig. 1 illustrated embodiment of an electrode line, partially cut, and

Fig. 6

a readout adapter according to the invention with an inserted electrode line according to FIG Fig. 1 and a sterile package in a cross section.

In the Fig. 1, 2 and 5 The electrode line 100 according to the invention shown with an external insulating jacket 102 is designed as a multi-lumen tube made of a suitable extrudable polymer. The electrode line 100 has an outer conductor 104 (for example a wire-wound coil or wire rope), one connected to a contact on the electrode tip (for example the tip electrode of a pacemaker electrode) Inner conductor 105 and an insulation layer 106 arranged between them. The outer conductor 104 is connected to another contact on the electrode tip (eg ring electrode of a pacemaker electrode).

The electrode line 100 also has a plug 111 in order to connect the electrode line 100 to the implant 300, for example. To establish contact between the electrode line 100 and the implant 300, the plug 111 has a tip contact 113 and one or more ring contacts 112. The tip contact 113 of the plug 111 can, for example, connect to the inner conductor 105 and the outer conductor 104 can connect to one of the ring contacts 112 of the plug 111 be connected.

The electrical conductors of the electrode line can, however, also be designed as non-coaxial cables and be present next to one another in the insulation jacket 102. Alternatively, only a single conductor can be arranged in the electrode line 100 (e.g. for a unipolar electrode or shock electrode).

The electrode line also has an ID circuit 200 embedded in the insulation jacket 102. A first connection of the connections 208 of the ID circuit 200 is electrically conductively connected to the outer conductor 104 and a second connection of the connections 208 of the ID circuit 200 is connected to an electrically conductive ring 110 arranged on the outside of the insulation jacket 102. The connection to the outer conductor 104 is advantageous because it can be implemented inexpensively. If the ID circuit 200 were to be connected to the inner conductor 105 instead, which is also possible in principle, the connection line would have to be guided through the outer conductor 104 in an insulated manner. The electrically conductive ring 110 makes the back contact of the ID circuit 200 via the body tissue to the housing of an implant 300, with which, as shown below, at least one individual property of the electrode line 100 can be read out. The electrically conductive ring 110 is therefore arranged at a predetermined distance from the plug, which is designed to be inserted into a socket of the implant 300 in order to connect the electrode line 100 to the implant 300. In the case of electrical conductors lying next to one another in the insulation jacket 102, the conductor-side connection 208 of the ID circuit 200 can be connected to one of the electrical conductors.

The ID circuit 200 is read out by means of alternating voltage. A rectifier 202 is therefore provided at connection 208 of ID circuit 200. The outputs of this rectifier are connected both to inputs for the voltage supply (V _CC , GND) of an ID chip 201 and to its signal inputs A and B. The connection is made via a protective resistor 203, which has a resistance of 50 kΩ, for example. A voltage limiter 204, for example a Zener diode or a varistor, is provided parallel to the inputs for the voltage supply. The effective value of the alternating voltage is, for example, 3 V with a frequency of 100 kHz. The rectifier has a dielectric strength which corresponds to the maximum voltage that occurs in the intended therapy operation, for example 1 kV. The connections 208 for the power supply simultaneously communicate with the signal inputs A, B of the ID chip 201, preferably by means of load modulation by a switching transistor 205. In order to secure the power supply of the ID chip 201 during the load modulation, the connections 208 for the power supply is wired with a switching diode 206 and a buffer capacitor 207. The buffer capacitor has a capacity of 1 nF, for example.

The ID chip 201 has a single-wire interface for communication with an ID communication unit 303 of the implant 300 for reading out at least one individual property (e.g. serial number, type designation, etc. see above) of the electrode line 100, which is stored in a memory unit of the ID chip 201 is stored. The memory unit of the ID chip preferably also has a writable memory area for writing in data which can be transmitted via the single-wire interface of the ID chip 201.

To query an electrode line according to Figures 1 and 2 for example, the in Figure 4 shown implant 300 can be used. The implant has a control unit 301 which is connected to a suitable multiplexer 302 and an ID communication unit 303. Furthermore, a therapy and diagnostic unit 304 and a telemetry unit 305 are provided, the Telemetry unit 305 is connected to an antenna 307. Both the telemetry unit 305 and the therapy and diagnostic unit 304 are also connected to the control unit 301. To read out an electrode line 100 connected to the implant 300, for example by inserting the plug of the electrode line 100 into a socket of the implant 300, the corresponding electrode connections 306 of the implant are connected to the ID communication unit 303 by the multiplexer 302. When the implant 300 is in therapy or diagnosis mode, the multiplexer 302 instead connects the electrode connections 306 to the therapy and diagnosis unit 304 of the implant 300.

For communication with the single-wire interface of the ID chip 201 of the ID circuit, a first predetermined connection of the implant 100 is connected to the external line 104 of the electrode line 100 by means of the multiplexer 302 and a second predetermined connection is connected to the housing of the implant 300. Furthermore, the ID communication unit 303 is activated. The control unit 301 now causes an effective alternating voltage of, for example, 3 V with a frequency of 100 kHz to be applied between the specified first and second connection, which is thus also applied to the connections 208 of the ID circuit 200. The ID communication unit 303 now reads out at least one individual property from the memory unit of the ID chip 201 via the single-wire interface and / or writes data into the writable memory area of the ID chip 201 via this interface. The data read out can be stored in a memory unit of the control unit 301 or transmitted to another device, for example an external patient device, via the telemetry unit 305. The patient device can transmit this information to a telemonitoring platform. It is also possible in this way to store information in a writable memory area of the memory unit of the ID chip 201 that comes from the control unit 301 of the implant 300 itself, from another device (e.g. patient device) or from a telemonitoring platform.

Using the information read out from the electrode line 100, the implant 300 can automatically determine the connection assignment of the electrode line and configure and / or adapt therapy parameters to the recognized electrode lead. The information read out from the electrode line, for example a serial number, can be used for documentation, product traceability (batch tracing), error analysis or its selection for certain applications.

In order to be able to read the information from the electrode line even when it is not implanted, for example packaged, an in Fig. 6 Readout adapter 400 shown, which has a coil 403 made of electrically conductive material, can be plugged onto the plug 111 of the electrode line 100 in such a way that its one connection (contact terminal 401) with the electrically conductive ring 110 and its other connection (contact terminal 401) with an electrical Conductor of the electrode line 100, for example with the outer conductor 104 via a ring contact 112 of the plug 111, is connected. The readout adapter 400 is preferably made of an electrically non-conductive, non-metallic material, for example plastic, epoxy resin, silicone, or the like. The readout adapter 400 can, for example, be designed in the shape of a cylinder or a cuboid, any other shape also being conceivable. The readout adapter contains, for example, a cylindrical recess (socket) 405, which is used to insert the plug 111 of the electrode line. The contact clips 401 protrude from the inner wall of the recess 405 and into the recess 405. The coil 403 is expanded to a resonance circuit by suitable wiring with a capacitor 402, the resonance frequency of which preferably corresponds to the working frequency of a readout device 500 different from the implant. Before the electrode conductor 100 is used, the combination of the inserted electrode conductor 100 and the readout adapter 400 is arranged in a closed sterile packaging 404. The sterile packaging 404 is also preferably made of an electrically non-conductive, non-metallic material.

In the state in which the read adapter is plugged onto the electrode line to be measured, this arrangement is similar in its mode of operation to an RFID transponder of a known type, for example an RFID transponder for the 125 kHz band. As a read-out device for reading and writing to the memory unit of the ID chip 201 In this arrangement, a known readout device 500 can be used for such an RFID transponder with an interrogation coil 501. With this arrangement, it is possible to read or write the electrode line 100 contactlessly by means of inductive coupling even through sterile packaging. The read-out device can contain a display on which the information that has been read can be displayed and / or contain an input option via which the information to be stored can be entered. Furthermore, the read-out device 500 can be connected with a data connection of a suitable type to a data network into which the information read out is transmitted or from which the information to be stored can be obtained.

List of reference symbols

100

Electrode lead

102

Insulation jacket

104

Outer conductor

105

Inner conductor

106

Insulation layer

110

electrically conductive ring

111

plug

112

Ring contact of plug 111

113

Tip contact of connector 111

200

ID circuit

201

ID chip

202

Rectifier

203

Protective resistance

204

Voltage limiter

205

Switching transistor

206

diode

207

Buffer capacitor

208

Connection of ID circuit 200 for power supply

300

Implant

301

Control unit

302

Connection multiplexer

303

ID communication unit

304

Therapy or diagnostic unit

305

Telemetry unit

306

Connections of the implant

307

antenna

400

Readout adapter

401

Contact clamp

402

Capacitor of the readout adapter 400

403

Read adapter coil 400

404

sterile packaging

405

Recess in readout adapter 400

500

RFID readout device

501

Interrogation coil of the RFID readout device 500

Claims (11)

1. An electrode lead (100), intended for connection to an implant (300) by means of a plug, with at least one electrical conductor (104, 105) and an insulation sleeve (102), comprising an ID circuit (200) which is arranged in the insulation sleeve (102) and has an ID chip (201), wherein the ID circuit (200) is connected by means of its first connector to an electrical conductor (104), wherein the ID chip (201) has a memory unit, wherein at least one individual property of the electrode lead (100), for example the associated ID number, batch number, type, the design, revision or the like, is stored in the memory unit, characterised in that the ID circuit (200) is connected by means of its second connector to an electrically conductive element (110) exposed externally on the electrode lead and the electrically conductive element (110) is arranged at a predefined distance from the plug in the longitudinal direction of the electrode lead (110).
2. The electrode lead (100) according to claim 1, characterised in that the ID chip (201) has a single-wire interface.
3. The electrode lead (100) according to one of the preceding claims, characterised in that the electrically conductive element is designed as an electrically conductive ring, wire, cable, stranded wire or foil (110).
4. The electrode lead (100) according to one of the preceding claims, characterised in that the memory unit has a writeable memory region.
5. The electrode lead (100) according to one of the preceding claims, characterised in that the ID circuit (200) has a switching transistor (205) which is connected parallel to the ID chip (201) and is used for communication with the implant (300) by means of load modulation.
6. The electrode lead (100) according to one of the preceding claims, characterised in that the ID circuit (200) has a voltage limiter (204).
7. The electrode lead (100) according to one of the preceding claims, characterised in that the ID circuit has a circuitry formed of diode (206) and buffer capacitor (207) for power supply during the load modulation.
8. A method for identifying an electrode lead (100) according to one of claims 1 to 7 by means of an implant (300), comprising the following steps:

   - connecting the first connector of the ID circuit (200) and the second connector of the ID circuit (200) to an ID communication unit (303) of the implant (300), wherein the first connector of the ID circuit is connected to a predefined electrical conductor (104) of the electrode lead (100) and the second connector of the ID circuit is connected to a housing of the implant (300),

   - applying an alternating voltage between the first connector and the second connector (208) of the ID circuit (200),

   - reading out at least one desired individual property from the memory unit of the ID chip (201) via a single-wire interface of the ID chip (201) by means of the ID communication unit (303),

   - storing the at least one read-out individual property in a memory unit of the implant (300).
9. The method according to claim 8, characterised in that predefined data are additionally written into a writeable memory region of the memory unit of the ID circuit (200) by the ID communication unit (303) via the single-wire interface.
10. A method for configuring a system consisting of an implant (300) and at least one electrode lead (100) according to one of claims 1 to 7, comprising the following steps:

    - identifying the at least one electrode lead (100) connected to the implant (300) by means of a method according to one of claims 8 to 9,

    - configuring the actuation of the connectors (306) of the implant (300) connected to the read-out electrode lead (100) and/or the therapy parameters.
11. An implant (300) having a socket for connection to the plug of an electrode lead (100) according to one of claims 1 to 7 and having a housing, with an ID communication unit (303) which is connectable to a predefined electrical conductor (104, 105) of the electrode lead (100) and to the housing of the implant (300) and is designed to generate an alternating voltage between housing and the predefined electrical conductor (104), wherein the ID communication unit is also designed to read out at least one desired individual property of the memory unit of the ID chip (201), preferably via a single-wire interface of the ID chip (201), and to store the at least one read-out individual property in a memory unit of the implant (300).

Images